16S Ribosomal Ribonucleic Acid Gene Polymerase Chain Reaction in the Diagnosis of Bloodstream Infections: A Systematic Review and Meta-Analysis

ObjectiveWe aim to evaluate the accuracy of the 16S ribosomal ribonucleic acid (rRNA) gene polymerase chain reaction (PCR) test in the diagnosis of bloodstream infections through a systematic review and meta-analysis.MethodsA computerized literature search was conducted to identify studies that assessed the diagnostic value of 16S rRNA gene PCR test for bloodstream infections. Study quality was assessed using the revised Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR) and their 95% confidence intervals (95% CI) for each study. Summary receiver operating characteristic (SROC) curve was used to summarize overall test performance. Statistical analysis was performed in Meta-DiSc 1.4 and Stata/SE 12.0 software.ResultsTwenty-eight studies were included in our meta-analysis. Using random-effect model analysis, the pooled sensitivity, specificity, PLR, NLR, and DOR were 0.87 (95% CI, 0.85–0.89), 0.94 (95% CI, 0.93–0.95), 12.65 (95% CI, 8.04–19.90), 0.14 (95% CI, 0.08–0.24), and 116.76 (95% CI, 52.02–262.05), respectively. The SROC curve indicated that the area under the curve (AUC) was 0.9690 and the maximum joint sensitivity and specificity (Q*) was 0.9183. In addition, heterogeneity was statistically significant but was not caused by the threshold effect.ConclusionExisting data suggest that 16S rRNA gene PCR test is a practical tool for the rapid screening of sepsis. Further prospective studies are needed to assess the diagnostic value of PCR amplification and DNA microarray hybridization of 16S rRNA gene in the future.     

Evaluation of a New Cryptococcal Antigen Lateral Flow Immunoassay in Serum,Cerebrospinal Fluid and Urine for the Diagnosis of Cryptococcosis: A Meta-Analysis and Systematic Review

BackgroundA new lateral flow immunoassay (LFA) for the detection of cryptococcal antigen was developed.ObjectiveWe aimed to systematically review all relevant studies to evaluate the diagnostic accuracy of the cryptococcal antigen LFA on serum, CSF and urine specimens.MethodsWe searched public databases including PubMed, Web of Science, Elsevier Science Direct and Cochrane Library for the English-language literature published up to September 2014. We conducted meta-analyses of sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR) and diagnostic odds ratios (DOR) and SROC of LFA in serum and CSF, respectively. The sensitivity of LFA in urine was also analyzed. Subgroup analyses were carried out to analyze the potential heterogeneity.Results12 studies were included in this study. The pooled sensitivity and specificity values of LFA in serum were 97.6% (95% CI, 95.6% to 98.9%) and 98.1% (95% CI, 97.4% to 98.6%), respectively. The average PLR of LFA in serum was 43.787 (95% CI, 22.60–84.81) and the NLR was 0.03 (95% CI, 0.01–0.09). The pooled DOR was 2180.30 (95% CI, 868.92–5471.00) and the AUC was 0.9968. The pooled sensitivity and specificity values of LFA in CSF were 98.9% (95% CI, 97.9% to 99.5%) and 98.9% (95% CI, 98.0% to 99.5%), respectively. The average PLR of LFA in serum was 48.83 (95% CI, 21.59–110.40) and the NLR was 0.02 (95% CI, 0.01–0.04). The pooled DOR was 2931.10 (95% CI, 1149.20–7475.90) and the AUC was 0.9974. The pooled sensitivity value of LFA in urine was 85.0% (95% CI, 78.7% to 90.1%)ConclusionsThe study demonstrates a very high accuracy of LFA in serum and CSF for the diagnosis of cryptococcosis in patients at risk. LFA in urine can be a promising sample screening tool for early diagnosis of cryptococcosis.     

Significance of Serum Pepsinogens as a Biomarker for Gastric Cancer and Atrophic Gastritis Screening: A Systematic Review and Meta-Analysis

Background

Human pepsinogens are considered promising serological biomarkers for the screening of atrophic gastritis (AG) and gastric cancer (GC). However, there has been controversy in the literature with respect to the validity of serum pepsinogen (SPG) for the detection of GC and AG. Consequently, we conducted a systematic review and meta-analysis to assess the diagnostic accuracy of SPG in GC and AG detection.

Methods

We searched PubMed, Embase, and the Chinese National Knowledge Infrastructure (CNKI) for correlative original studies published up to September 30, 2014. The summary sensitivity, specificity, positive diagnostic likelihood ratio (DLR+), negative diagnostic likelihood ratio (DLR-), area under the summary receiver operating characteristic curve (AUC) and diagnostic odds ratio (DOR) were used to evaluate SPG in GC and AG screening based on bivariate random effects models. The inter-study heterogeneity was evaluated by the I² statistics and publication bias was assessed using Begg and Mazumdar’s test. Meta-regression and subgroup analyses were performed to explore study heterogeneity.

Results

In total, 31 studies involving 1,520 GC patients and 2,265 AG patients were included in the meta-analysis. The summary sensitivity, specificity, DLR+, DLR-, AUC and DOR for GC screening using SPG were 0.69 (95% CI: 0.60–0.76), 0.73 (95% CI: 0.62–0.82), 2.57 (95% CI: 1.82–3.62), and 0.43 (95% CI: 0.34–0.54), 0.76 (95% CI: 0.72–0.80) and 6.01 (95% CI: 3.69–9.79), respectively. For AG screening, the summary sensitivity, specificity, DLR+, DLR-, AUC and DOR were 0.69 (95% CI: 0.55–0.80), 0.88 (95% CI: 0.77–0.94), 5.80 (95% CI: 3.06–10.99), and 0.35 (95% CI: 0.24–0.51), 0.85 (95% CI: 0.82–0.88) and 16.50 (95% CI: 8.18–33.28), respectively. In subgroup analysis, the use of combination of concentration of PGI and the ratio of PGI:PGII as measurement of SPG for GC screening yielded sensitivity of 0.70 (95% CI: 0.66–0.75), specificity of 0.79 (95% CI: 0.79–0.80), DOR of 6.92 (95% CI: 4.36–11.00), and AUC of 0.78 (95% CI: 0.72–0.81), while the use of concentration of PGI yielded sensitivity of 0.55 (95% CI: 0.51–0.60), specificity of 0.79 (95% CI: 0.76–0.82), DOR of 6.88 (95% CI: 2.30–20.60), and AUC of 0.77 (95% CI: 0.73–0.92). For AG screening, the use of ratio of PGI:PGII as measurement of SPG yielded sensitivity of 0.69 (95% CI: 0.52–0.83), specificity of 0.84 (95% CI: 0.68–0.93), DOR of 11.51 (95% CI: 6.14–21.56), and AUC of 0.83 (95% CI: 0.80–0.86), the use of combination of concentration of PGI and the ratio of PGI:PGII yield sensitivity of 0.79 (95% CI: 0.72–0.85), specificity of 0.89 (95% CI: 0.85–0.93), DOR of 24.64 (95% CI: 6.95–87.37), and AUC of 0.87 (95% CI: 0.81–0.92), concurrently, the use of concentration of PGI yield sensitivity of 0.46 (95% CI: 0.38–0.54), specificity of 0.93 (95% CI: 0.91–0.95), DOR of 19.86 (95% CI: 0.86–456.91), and AUC of 0.86 (95% CI: 0.52–1.00).

Conclusion

SPG has great potential as a noninvasive, population-based screening tool in GC and AG screening. In addition, given the potential publication bias and high heterogeneity of the included studies, further high quality studies are required in the future.     

Diagnostic Accuracy of Lipopolysaccharide-Binding Protein as Biomarker for Sepsis in Adult Patients: A Systematic Review and Meta-Analysis

IntroductionLipopolysaccharide-binding protein (LBP) is widely reported as a biomarker to differentiate infected from non-infected patients. The diagnostic use of LBP for sepsis remains a matter of debate. We aimed to perform a systematic review and meta-analysis to assess the diagnostic accuracy of serum LBP for sepsis in adult patients.MethodsWe performed a systematic review and meta-analysis to assess the accuracy of LBP for sepsis diagnosis. A systematic search in PubMed and EMBASE for studies that evaluated the diagnostic role of LBP for sepsis through December 2015 was conducted. We searched these databases for original, English language, research articles that studied the diagnostic accuracy between septic and non-septic adult patients. Sensitivity, specificity, and other measures of accuracy, such as diagnostic odds ratio (DOR) and area under the receiver operating characteristic curve (AUC) of LBP were pooled using the Hierarchical Summary Receiver Operating Characteristic (HSROC) method.ResultsOur search returned 53 reports, of which 8 fulfilled the inclusion criteria, accounting for 1684 patients. The pooled sensitivity and specificity of LBP for diagnosis of sepsis by the HSROC method were 0.64 (95% CI: 0.56–0.72) and 0.63 (95% CI: 0.53–0.73), respectively. The value of the DOR was 3.0 (95% CI: 2.0–4.0) and the AUC was 0.68 (95% CI: 0.64–0.72). Meta-regression analysis revealed that cut-off values accounted for the heterogeneity of sensitivity and sample size (> = 150) accounted for the heterogeneity of specificity.ConclusionsBased on the results of our meta-analysis, LBP had weak sensitivity and specificity in the detection of sepsis. LBP may not be practically recommended for clinical utilization as a single biomarker.     

Interleukin-8 for Diagnosis of Neonatal Sepsis: A Meta-Analysis

BackgroundNeonatal sepsis (NS) is a life-threatening disorder and an important cause of morbidity and mortality in neonates. Previous studies showed that interleukin 8 (IL-8) may effectively and rapidly diagnose NS.ObjectiveWe conducted the systematic review and meta-analysis to investigate the diagnostic value of the IL-8 in NS.MethodsThe literature was searched in PUBMED, EMBASE, Cochrane Library, CNKI, VIP and other Chinese Medical Databases during October 1998 to January 2014 using set search criteria. Each included study was evaluated by quality assessment of diagnostic accuracy studies tool. Two investigators independently extracted the data and study characteristics, and disagreements, if any, were resolved by consensus. Meta-disc software was used to calculate the pooled sensitivity, specificity and summary diagnostic odds ratio (SDOR), I² or Cochrane Q to test heterogeneity, and meta-regression to investigate the source of heterogeneity. Funnel plots were used to test the potential presence of publication bias. False-positive report probability (FPRP) was calculated to confirm the significance of the results.ResultsEight studies (548 neonates) were included in this meta-analysis. The pooled sensitivity and specificity of IL-8 were 0.78 and 0.84, respectively, which had moderate accuracy in the diagnosis of NS. The pooled diagnostic odds ratio (DOR) and area under curve (AUC) was 21.64 and 0.8908 (Q*=0.8215), respectively. The diagnostic threshold analysis showed that there was no threshold effect. The meta-regression analysis showed the cut-off, QUADAS and onset time have no effect on the heterogeneity. The funnel plots showed the existence of publication bias.ConclusionMeta-analysis showed IL-8 had a moderate accuracy (AUC=0.8908) for the diagnosis of NS. IL-8 is a helpful biomarker for early diagnosis of NS. However, we should combine the results with clinical symptoms and signs, laboratory and microbial results.     

Diagnostic Performance of Whole-Body PET/MRI for Detecting Malignancies in Cancer Patients: A Meta-Analysis

BackgroundAs an evolving imaging modality, PET/MRI is preliminarily applied in clinical practice. The aim of this study was to assess the diagnostic performance of PET/MRI for tumor staging in patients with various types of cancer.MethodsRelevant articles about PET/MRI for cancer staging were systematically searched in PubMed, EMBASE, EBSCO and the Cochrane Library. Two researchers independently selected studies, extracted data and assessed the methodological quality using the QUADAS tool. The pooled sensitivity, specificity, diagnostic odds ratio (DOR), positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated per patient and per lesion. The summary receiver-operating characteristic (SROC) curves were also constructed, and the area under the curve (AUC) and Q* estimates were obtained.ResultsA total of 38 studies that involved 753 patients and 4234 lesions met the inclusion criteria. On a per-patient level, the pooled sensitivity and specificity with 95% confidence intervals (CIs) were 0.93 (0.90–0.95) and 0.92 (0.89–0.95), respectively. On a per-lesion level, the corresponding estimates were 0.90 (0.88–0.92) and 0.95 (0.94–0.96), respectively. The pooled PLR, NLR and DOR estimates were 6.67 (4.83–9.19), 0.12 (0.07–0.21) and 75.08 (42.10–133.91) per patient and 10.91 (6.79–17.54), 0.13 (0.08–0.19) and 102.53 (59.74–175.97) per lesion, respectively.ConclusionAccording to our results, PET/MRI has excellent diagnostic potential for the overall detection of malignancies in cancer patients. Large, multicenter and prospective studies with standard scanning protocols are required to evaluate the diagnostic value of PET/MRI for individual cancer types.     

Confluent Granulomas and Ulcers Lined by Epithelioid Histiocytes: New Ideal Method for Differentiation of ITB and CD? A Meta Analysis

Background

There are few widely accepted criteria other than caseation, which has low sensitivity, for differentiating intestinal tuberculosis (ITB) and Crohn''s disease (CD).

Objective

We performed a meta-analysis to evaluate the use of confluent granulomas and ulcers lined by epithelioid histiocytes as histological methods for differentiating ITB and CD, compared with that of caseation.

Methods

We searched PubMed, Medline, Embase, Web of Science, the Cochrane Library and Chinese Biomedicine Database for all relevant studies on the histological differentiation of ITB and CD. Sensitivity, specificity, and diagnostic odds ratio (DOR) were calculated for each study. Study quality and heterogeneity were assessed. Meta-regression analysis and sensitivity analyses were performed.

Results

Ten randomized trials involving 316 ITB and 376 CD patients were included. The results showed that analysis of caseation showed an overall weighted area under the curve (AUC) of 0.9966, overall sensitivity and specificity were 0.21 and 1.00, respectively, with a positive likelihood ratio (+LR) of 10.79, negative likelihood ratio(-LR) of 0.82 and DOR of 13.74. Confluent granulomas had a lower overall weighted AUC of 0.9381, sensitivity and specificity were 0.38 and 0.99, respectively, with a +LR of 16.29, -LR of 0.65 and DOR of 26.52. Overall weighted AUC for ulcers lined by epithelioid histiocytes was 0.9017, sensitivity and specificity were 0.41 and 0.94, respectively, with a +LR of 6.46, -LR of 0.54 and DOR of 13.17. Significant heterogeneity was noted for the studies. Meta-regression analysis showed that study source, publication year, size, design and quality did not affect heterogeneity.

Conclusion

Confluent granulomas and ulcers lined by epithelioid histiocytes are helpful in distinguishing ITB from CD, which may provide a new method, other than caseating granulomas and acid-fast bacilli, to differentiate ITB and CD in mucosal biopsies.     

代谢综合征患者肥胖和脂质代谢参数的特征及其诊断价值

目的:比较代谢综合征(MetS)患者不同肥胖和脂质代谢参数的特征和其对疾病的诊断价值。方法:回顾性分析2016年1月至2018年12月在我院就诊的MetS患者和健康体检者,比较其体重指数(Body Mass Index, BMI)、腰高比(Waist-to-Height Ratio,WHt R)、甘油三酯/高密度脂蛋白胆固醇(TG/HDL-C)、脂肪蓄积指数(Lipid accumulation product, LAP)和内脏脂肪指数(Visceral adiposity index,VAI)的差异及不同代谢因素分组患者上述参数差异。采用ROC曲线评价不同肥胖和脂质代谢参数对MetS的诊断价值。结果:与健康组相比,MetS组无论男性还是女性患者BMI、WC、WHt R、血压、FPG、TG、TG/HDL-C、LAP和VAI均明显升高,而HDL-C显著降低(P0.05)。随着MetS特征个数的增加,MetS组患者的BMI、WHt R、TG/HDL-C、LAP和VAI均呈现显著增加趋势(P0.05)。上述五个诊断MetS的ROC曲线中都是LAP的AUC最大,男性AUC为0.896,敏感度为0.75,特异度为0.84。女性LAP的AUC为0.874,最佳诊断切点为31.05,此时的敏感度为0.74,特异度为0.92。结论:LAP对代谢综合征的诊断效能最高,男性LAP大于26.36、女性LAP大于31.05有助于诊断代谢综合征患者。     

Spleen Stiffness Is Superior to Liver Stiffness for Predicting Esophageal Varices in Chronic Liver Disease: A Meta-Analysis

MethodsPubmed/Medline, Embase, Cochrane Library and Ovid were searched for all studies assessing SS and LS simultaneously in EV diagnosis. A total of 16 studies including 1892 patients were included in this meta-analysis, and the pooled statistical parameters were calculated using the bivariate mixed effects models.ResultsIn detection of any EV, for LS measurement, the summary sensitivity was 0.83 (95% confidence interval [CI]: 0.78–0.87), and the specificity was 0.66 (95% CI: 0.60–0.72). While for SS measurement, the pooled sensitivity and specificity was 0.88 (95% CI: 0.83–0.92) and 0.78 (95% CI: 0.73–0.83). The summary receiver operating characteristic (SROC) curve values of LS and SS were 0.81 (95% CI: 0.77–0.84) and 0.88 (95% CI: 0.85–0.91) respectively, and the results had statistical significance (P<0.01). The diagnostic odds ratio (DOR) of SS (25.73) was significantly higher than that of LS (9.54), with the relative DOR value was 2.48 (95%CI: 1.10–5.60), P<0.05.ConclusionsUnder current techniques, SS is significantly superior to LS for identifying the presence of EV in patients with CLD. SS measurement may help to select patients for endoscopic screening.     

Myocardial Infarction Detection and Localization Using Optimal Features Based Lead Specific Approach

ObjectivesObjective of this paper is to present a reliable and accurate technique for Myocardial Infarction (MI) detection and localization.Material and methodsStationary wavelet transform has been used to decompose the ECG signal. Energy, entropy and slope based features were extracted at specific wavelet bands from selected lead of ECG. k-Nearest Neighbors (kNN) with Mahalanobis distance function has been used for classification. Sensitivity (Se), specificity (Sp), positive predictivity (+P), accuracy (Acc), and area under the receiver operating characteristics curve (AUC) analyzed over 200 subjects (52 health control, 148 with MI) from Physikalisch-Technische Bundesanstalt (PTB) database has been used for performance analysis. To handle the imbalanced data adaptive synthetic (ADASYN) sampling approach has been adopted.ResultsFor detection of MI, the proposed technique has shown an AUC = 0.99, Se = 98.62%, Sp = 99.40%, PPR = 99.41% and Acc = 99.00% using 12 top ranked features, extracted from multiple leads of ECG and AUC = 0.99, Se = 98.34%, Sp = 99.77%, PPR = 99.77% and Acc = 99.05% using 12 features extracted from a single ECG lead (i.e. lead V5). For localization of MI, the proposed technique has an AUC = 0.99, Se = 98.78%, Sp = 99.86%, PPR = 98.80%, and Acc = 99.76% using 5 top ranked features from multiple leads of ECG and AUC = 0.98, Se = 96.47%, Sp = 99.60%, PPR = 96.49% and Acc = 99.28% using 8 features extracted from a single ECG lead (i.e. lead V3).ConclusionThus for MI detection and localization, the proposed technique is independent of time-domain ECG fiducial markers and can work using specific leads of ECG.     

Assessment of the Potential Diagnostic Role of Anaplastic Lymphoma Kinase for Inflammatory Myofibroblastic Tumours: A Meta-Analysis

Objective

To assess the value of anaplastic lymphoma kinase for the diagnosis of inflammatory myofibroblastic tumours using a comprehensive meta-analysis.

Methods

We searched the related literature using electronic databases and manual searches. Approximately 454 cases from several countries were included in this analysis. The quality of studies included was assessed by QUADAS (quality assessment of studies of diagnostic accuracy). The diagnostic odds ratio (DOR), positive likelihood ratio (PLR), negative likelihood ratio (NLR), sensitivity and specificity were calculated to assess the role of anaplastic lymphoma kinase in the diagnosis of inflammatory myofibroblastic tumours. The overall test performance was summarised by an SROC (summary receiver operating characteristic curve). The heterogeneity and publication bias were analysed using Meta-regression and Deeks'' test. All data were analysed by Stata 12.0 software.

Results

Eight studies were included according to our inclusion criteria. The overall results for the specificity, sensitivity, PLR, NLR, DOR and area under the curve (AUC) were 0.99 (95% CI 0.82-1.00), 0.67 (95% CI 0.46-0.83), 0.67 (95% CI 0.46-0.83), 60.6 (95% CI 3.3-1112.4), 0.33 (95% CI 0.19-0.60), 181 (95% CI 9-3684) and 0.95 (95% CI 0.93-0.97), respectively, while the specificity, sensitivity, PLR, NLR, DOR and AUC for bladder IMTs were 0.99 (95% CI 0.67-1.00), 0.86 (95% CI 0.58-0.96), 95.6 (95% CI 2.0-4616.2), 0.14 (95% CI 0.04-0.50), 671 (95% CI 16-28913) and 0.99 (95% CI 0.97-0.99), respectively.

Conclusion

The present meta-analysis indicated that anaplastic lymphoma kinase plays a significant role in the differential diagnosis of inflammatory myofibroblastic tumours, particularly for inflammatory myofibroblastic tumours of the urinary bladder.     

Diagnostic utility of MR-proANP and NT-proBNP in elderly outpatients with a high risk of heart failure: the Copenhagen heart failure risk study

Abstract

Background: Amino-terminal-pro-B-type-natriuretic-peptide (NT-proBNP) is a diagnostic biomarker for heart failure (HF), but plasma concentrations are influenced by numerous factors. Mid-regional-pro-atrial-natriuretic-peptide (MR-proANP) have comparable diagnostic value in acute HF. However, data are lacking in the non-acute setting. This study sought to assess the diagnostic utility of MR-proANP in outpatients with a high risk of HF.

Methods: This prospective study included 399 outpatients. Inclusion criteria were: age?≥?60?years, ≥1 risk factor for HF (diabetes, chronic kidney disease, vascular disease, atrial fibrillation, hypertension), without known or suspected HF. Unrecognized HF was diagnosed based on clinical signs, patient-reported symptoms and echocardiography. Plasma concentrations of MR-proANP and NT-proBNP were analysed.

Results: In total, 65 patients were diagnosed with HF or asymptomatic left ventricular systolic dysfunction (N?=?12 LVEF?≤?40%, N?=?7 LVEF?>?40% to ≤50%, N?=?46 LVEF?>?50%). Both MR-proANP (odds-ratio: 1.77; 95% CI:1.16–2.72; p?=?0.009) and NT-proBNP (odds-ratio: 1.49; 95% CI:1.22–1.82; p?<?0.001) were associated with HF. Area under receiver-operator characteristics curve (AUC) for the diagnosis of HF or asymptomatic left ventricular systolic dysfunction was higher for MR-proANP (AUC?=?0.886; p?<?0.001) and NT-proBNP (AUC?=?0.910; p?<?0.001) compared to patient-reported symptoms of HF (AUC?=?0.830), but NT-proBNP added more diagnostic information compared to MR-proANP (p?=?0.022).

Conclusions: Both NT-proBNP and MR-proANP are useful biomarkers in the diagnosis of HF or asymptomatic left ventricular systolic dysfunction in a non-acute setting. However, NT-proBNP added more diagnostic information compared to MR-proANP.     

Accuracy of i-Scan for Optical Diagnosis of Colonic Polyps: A Meta-Analysis

Backgroundi-Scan is a novel virtual chromoendoscopy system designed to enhance surface and vascular patterns to improve optical diagnostic performance. Numerous prospective studies have been done to evaluate the accuracy of i-Scan in differentiating colonic neoplasms from non-neoplasms. i-Scan could be an effective endoscopic technique for optical diagnosis of colonic polyps.ObjectiveOur aim of this study was to perform a meta-analysis of published data to establish the diagnostic accuracy of i-Scan for optical diagnosis of colonic polyps.MethodsWe searched PubMed, Medline, Elsevier ScienceDirect and Cochrane Library databases. We used a bivariate meta-analysis following a random effects model to summarize the data and plotted hierarchical summary receiver-operating characteristic (HSROC) curves. The area under the HSROC curve (AUC) serves as an indicator of the diagnostic accuracy.ResultsThe meta-analysis included a total of 925 patients and 2312 polyps. For the overall studies, the area under the HSROC curve was 0.96. The summary sensitivity was 90.4% (95%CI 85%-94.1%) and specificity was 90.9% (95%CI 84.3%-94.9%). In 11 studies predicting polyps histology in real-time, the summary sensitivity and specificity was 91.5% (95%CI 85.7%-95.1%) and 92.1% (95%CI 84.5%-96.1%), respectively, with the AUC of 0.97. For three different diagnostic criteria (Kudo, NICE, others), the sensitivity was 86.3%, 93.0%, 85.0%, respectively and specificity was 84.8%, 94.4%, 91.8%, respectively.ConclusionsEndoscopic diagnosis with i-Scan has accurate optical diagnostic performance to differentiate neoplastic from non-neoplastic polyps with an area under the HSROC curve exceeding 0.90. Both the sensitivity and specificity for diagnosing colonic polyps are over 90%.     

Evaluation of the Diagnostic Accuracy of Prototype Rapid Tests for Human African Trypanosomiasis

BackgroundDiagnosis of human African trypanosomiasis (HAT) remains a challenge both for active screening, which is critical in control of the disease, and in the point-of-care scenario where early and accurate diagnosis is essential. Recently, the first field deployment of a lateral flow rapid diagnostic test (RDT) for HAT, “SD BIOLINE HAT” has taken place. In this study, we evaluated the performance of “SD BIOLINE HAT” and two new prototype RDTs.Conclusions/SignificanceBoth “SD BIOLINE HAT” and the prototype devices performed comparably well to one another and also to the published performance range of the card agglutination test for trypanosomiasis in sensitivity and specificity. The performance of individual antigens enabled us to predict that an all-recombinant antigen RDT can be developed with an accuracy equivalent to “ SD BIOLINE HAT.” Such an RDT would have advantages in simplified manufacture, lower unit cost and assured reproducibility.     

Cost effectiveness analysis of screening for sight threatening diabetic eye disease

ObjectiveTo measure the cost effectiveness of systematic photographic screening for sight threatening diabetic eye disease compared with existing practice.DesignCost effectiveness analysisSettingLiverpool.SubjectsA target population of 5000 diabetic patients invited for screening.ResultsBaseline prevalence of sight threatening eye disease was 14.1%. The cost effectiveness of the systematic programme was £209 (sensitivity 89%, specificity 86%, compliance 80%, annual cost £104 996) and of the opportunistic programme was £289 (combined sensitivity 63%, specificity 92%, compliance 78%, annual cost £99 981). The incremental cost effectiveness of completely replacing the opportunistic programme was £32. Absolute values of cost effectiveness were highly sensitive to varying prevalence, sensitivity and specificity, compliance, and programme size.ConclusionReplacing existing programmes with systematic screening for diabetic eye disease is justified.     

Development and Validation of an Osteoporosis Self-Assessment Tool for Taiwan (OSTAi) Postmenopausal Women-A Sub-Study of the Taiwan OsteoPorosis Survey (TOPS)

Background

To develop an OSTAi tool and compare this with the National Osteoporosis Foundation recommendations in 2013 (NOF 2013) for bone mineral density (BMD) testing among Taiwan postmenopausal women.

Methods

Taiwan Osteoporosis Association (TOA) conducted a nationwide BMD survey by a bus installed with a dual energy X-ray absorptiometry (DXA) between 2008 and 2011. All of the participants completed questionnaire, which included demographics and risk factors of osteoporotic fracture in FRAX tool. We used the database to analyze potential risk factors for osteoporosis and followed the model by Koh et al. to develop a risk index via multiple variable regression analysis and item reduction. We used the index values to set up a simple algorithm (namely OSTAi) to identify those who need BMD measurement. Receiver operating characteristic (ROC) curve and the area under the curve (AUC) was used to compare the sensitivity/specificity analysis of this model with that of recommendations by NOF 2013.

Results

A total of 12,175 Taiwan postmenopausal women enrolled in this survey. The index value was derived by age and body weight of the participants according to weighted odds of each risk factor and the selected cutoff value was set at “-1”. There are 6393 (52.5%) participants whose index value is below “-1” and whose risk of osteoporosis was 57.5% (3674/6393). The AUC for OSTAi and NOF 2013 were 0.739 (95% confidence interval (CI), 0.728–0.749, P<0.001) and 0.618 (95% CI, 0.606–0.630, P<0.001), respectively. The sensitivity and specificity of OSTAi, at the selected cutoff value of -1, and NOF 2013 to identify osteoporosis were 73.1%, 62.0% and 78.3%, 45.7%, respectively.

Conclusions

As OSTA for Asian populations, OSTAi is an useful tool to identify Taiwan postmenopausal women with osteoporosis, In comparison with NOF 2013, OSTAi may be an easier and better tool for referral to BMD measurement by DXA in this area.     

彩色多普勒超声联合血清CEA、CA125、TK1、TFF1对乳腺癌的诊断价值研究

摘要 目的：探究彩色多普勒超声联合血清癌胚抗原（CEA）、糖类抗原125（CA125）、胸苷激酶1（TK1）、三叶因子1（TFF1）对乳腺癌的诊断价值。方法：回顾性选取2019年1月到2022年1月间我院收治的97例乳腺癌患者为观察组,同期收治的97例乳腺良性病变患者为对照组,均行彩色多普勒超声检查及血清CEA、CA125、TK1、TFF1检测,比较两组超声特征、超声参数[搏动指数（PI）、收缩期峰值流速（PSV）、阻力指数（RI）],比较两组血清CEA、CA125、TK1、TFF1水平,通过受试者工作特征（ROC）曲线分析彩色多普勒超声联合血清CEA、CA125、TK1、TFF1诊断价值及单独诊断价值。结果：与对照组比较,观察组肿块边界不清晰、内部回声不均匀、形态不规则和钙化比例明显升高（P＜0.05）。与对照组比较,观察组患者RI、PSV、PI明显升高（P＜0.05）;其中观察组血流信号分级Ⅲ级比例明显高于对照组（P＜0.05）,观察组血流信号分级0级比例明显低于对照组（P＜0.05）。与对照组比较,观察组患者血清CEA、CA125、TK1、TFF1水平明显升高（P＜0.05）。ROC曲线发现,超声诊断乳腺癌的曲线下面积（AUC）值、灵敏度、特异度依次为0.773、76.30%、78.40%。CEA诊断乳腺癌的AUC值、灵敏度、特异度依次为0.774、78.40%、74.23%。CA125诊断乳腺癌的AUC值、灵敏度、特异度依次为0.824、77.31%、80.41%。TK1诊断乳腺癌的AUC值、灵敏度、特异度依次为0.818、78.43%、81.42%。TFF1诊断乳腺癌的AUC值、灵敏度、特异度依次为0.806、78.42%、77.31%。彩色多普勒超声联合血清CEA、CA125、TK1、TFF1诊断乳腺癌的AUC值0.929,显著优于各项指标单独使用（P＜0.05）。结论：与各项指标单一应用相比,彩色多普勒超声联合血清CEA、CA125、TK1、TFF1诊断乳腺癌的价值较高,有助于乳腺癌的早期筛查。     

Influence of diabetes on natriuretic peptide thresholds in screening for Stage B heart failure

Context: Natriuretic peptide (NP) has been shown to be an effective screening tool to identify patients with Stage B heart failure and to have clinical value in preventing heart failure progression. The impact of associated metabolic confounders on the screening utility of NP needs clarification.

Objective: To assess the impact of diabetes mellitus (DM) on NP screening for asymptomatic Stage B heart failure.

Materials and methods: The study population consisted of 1368 asymptomatic patients with cardiovascular risk factors recruited from general practice as part of the STOP-HF trial. B-type NP (BNP) was quantified at point-of-care.

Results: BNP was found to be as accurate for detecting Stage B heart failure in DM patients compared to non-DM patients (AUC 0.75 [0.71,0.78] and 0.77 [0.72,0.82], respectively). However, different BNP thresholds are required to achieve the same level of diagnostic sensitivity in DM compared with non-DM patients. To achieve 80% sensitivity a difference of 5-ng/L lower is required for patients with DM.

Conclusion: Although a significantly different BNP threshold is detected for patients with DM, the BNP concentration difference is small and unlikely to warrant a clinically different diagnostic threshold.     

Diagnostic Value of Circulating Chromogranin A for Neuroendocrine Tumors: A Systematic Review and Meta-Analysis

Background

In previous decades, chromogranin A (CgA) has been demonstrated to be the most promising biomarker for the diagnosis of neuroendocrine tumors (NETs), but its diagnostic value is still controversial. This meta-analysis aimed to estimate the potential diagnostic value of circulating CgA for NETs.

Methods

We collected relevant studies from several electronic databases as well as from reference lists. Diagnostic indices of CgA were pooled with random effects models. Pooled sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR) and summary receiver operating characteristic (SROC) curves for the diagnosis of NETs were used to estimate the overall diagnostic efficiency.

Results

Through a search strategy, 13 studies met the inclusion criteria and were included. These studies contained 1260 patients with NETs and 967 healthy controls in the total sample. As a result, the overall sensitivity, specificity and diagnostic odds ratio (DOR) were 0.73 (95% CI: 0.71 to 0.76), 0.95 (95% CI: 0.93 to 0.96) and 56.29 (95% CI: 25.27 to 125.38), respectively, while the summary positive likelihood ratio (PLR) and negative likelihood ratio (NLR) were 14.56 (95% CI: 6.62 to 32.02) and 0.26 (95% CI: 0.18 to 0.38), respectively. In addition, the area under the curve (AUC) of the circulating CgA in the diagnosis of NETs was 0.8962.

Conclusions

These data demonstrate that circulating CgA is an efficient biomarker for the diagnosis of NETs with high sensitivity and specificity, which indicates that it may be helpful for the clinical management of NETs. However, further studies are needed to clarify this issue.     

Field evaluation of a novel,rapid diagnostic assay,and molecular epidemiology of enterotoxigenic E. coli among Zambian children presenting with diarrhea

BackgroundEnterotoxigenic Escherichia coli (ETEC) is one of the top aetiologic agents of diarrhea in children under the age of 5 in low-middle income countries (LMICs). The lack of point of care diagnostic tools for routine ETEC diagnosis results in limited data regarding the actual burden and epidemiology in the endemic areas. We evaluated performance of the novel Rapid LAMP based Diagnostic Test (RLDT) for detection of ETEC in stool as a point of care diagnostic assay in a resource-limited setting.MethodsWe conducted a cross-sectional study of 324 randomly selected stool samples from children under 5 presenting with moderate to severe diarrhea (MSD). The samples were collected between November 2012 to September 2013 at selected health facilities in Zambia. The RLDT was evaluated by targeting three ETEC toxin genes [heat labile toxin (LT) and heat stable toxins (STh and STp)]. Quantitative PCR was used as the “gold standard” to evaluate the diagnostic sensitivity and specificity of RLDT for detection of ETEC. We additionally described the prevalence and seasonality of ETEC.ResultsThe study included 324 participants, 50.6% of which were female. The overall prevalence of ETEC was 19.8% by qPCR and 19.4% by RLDT. The children between 12 to 59 months had the highest prevalence of 22%. The study determined ETEC toxin distribution was LT 28/321(9%), ST 18/321(6%) and LT/ST 16/321(5%). The sensitivity and specificity of the RLDT compared to qPCR using a Ct 35 as the cut-off, were 90.7% and 97.5% for LT, 85.2% and 99.3% for STh and 100% and 99.7% for STp, respectively.ConclusionThe results of this study suggest that RLDT is sufficiently sensitive and specific and easy to implement in the endemic countries. Being rapid and simple, the RLDT also presents as an attractive tool for point-of-care testing at the health facilities and laboratories in the resource-limited settings.